The MARY-JANE Cannabis and Heart Rhythm Trial

NCT06021613 | Active Not Recruiting

• 1 other identifier: 23-39656
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

Despite recreational cannabis now being legal in 23 states, where more than 100 million Americans reside, studies on the actual health effects are limited. This study is a randomized trial, where each participant will be instructed to consume or avoid cannabis on randomly assigned days during a 14-day monitoring period. The goal of this study is to answer the question: "Does cannabis use increase the frequency of 'early' and abnormal heart beats?" During the 14-day period, participants will wear an external heart monitor, a glucose monitor, and a fitness tracker to track heart rhythm, glucose levels, step counts, and sleep health. Participants will use a mobile app or a text messaging service for daily instructions/reminders on cannabis use, and short surveys. The investigators ask that participants smoke or vape cannabis at least once on days they are instructed to consume cannabis. Compelling evidence of heart and other health effects would be important to the clinical care of our patients.

Conditions

Premature Atrial Contractions; Premature Ventricular Contractions

Keywords

Cannabis; Marijuana; Weed; Arrhythmias; Cardiac Ectopy; PACs; PVCs; Heart Rhythm

Outcome Measures

Primary Outcomes (1)

• Change in PAC and PVC frequencies

  Participants will be wearing a continuously recording ECG monitor for two weeks. The primary outcome will be change in premature atrial contraction (PAC) and PVC frequency due to cannabis consumption or avoidance during the monitoring period.

  Baseline and after completion of cannabis consumption, up to 2 weeks

Secondary Outcomes (5)

• Change in SVT episodes

  Baseline and after completion of cannabis consumption, up to 2 weeks

• Change in VT episodes

  Baseline and after completion of cannabis consumption, up to 2 weeks

• Mean daily glucose levels

  2 weeks

• Mean step count

  2 weeks

• Mean sleep duration

  2 weeks

Study Arms (1)

Case-crossover

EXPERIMENTAL

Participants will be randomized in two-day blocks to consume then avoid cannabis ("Start: On Cannabis") or avoid then consume cannabis ("Start: Off Cannabis"). Using an case-crossover strategy delivered by the NIH-funded, UCSF-run Eureka platform utilizing a mobile smartphone-based application, or the Mosio text messaging software for clinical research, participants will receive instructions and answer questions to help researchers and physicians understand the relationship between inhaled cannabis and heart rhythm.

Behavioral: Randomized instructions

Interventions

Randomized instructions BEHAVIORAL

Behavioral: Start: On Cannabis- In this two-day block, participants will be instructed to consume cannabis for one day and avoid cannabis the next day. Participants will be asked to smoke or vape cannabis at least once on days they are instructed to consume cannabis. Behavioral: Start: Off Cannabis- In this two-day block, participants will be instructed to avoid cannabis for one day and consume cannabis the next day. Participants will be asked to smoke or vape cannabis at least once on days they are instructed to consume cannabis.

Case-crossover

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Are age 21 or older
• Have a smartphone
• Are able to use the Eureka mobile application and Mosio text messaging software
• Have inhaled cannabis in the past month and on at least four different days in the same week in the past year
• Are willing to consume and abstain from inhaled cannabis for no more than two consecutive days as instructed over the 14-day trial period
• Are able to participate in a location where cannabis use would not break any established laws under any jurisdiction
• Are able to self supply cannabis throughout the study duration

You may not qualify if:

• Currently pregnant or trying to get pregnant
• Have a medical reason to avoid cannabis
• Are unwilling to avoid all forms of cannabis consumption on days instructed to abstain from cannabis
• Are currently taking anti-arrhythmic medications
• Have a history of atrial fibrillation or heart failure
• Have congenital heart disease
• Have an implantable cardioverter-defibrillator or pacemaker
• Have had a previous cardiac ablation procedure
• Are currently taking insulin
• Are unable to read or sign to provide informed consent

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (2)

UCSF Medical Center at Parnassus

San Francisco, California, 94143, United States

Location

UCSF Medical Center at Mission Bay

San Francisco, California, 94158, United States

Location

Related Publications (10)

• Colilla S, Crow A, Petkun W, Singer DE, Simon T, Liu X. Estimates of current and future incidence and prevalence of atrial fibrillation in the U.S. adult population. Am J Cardiol. 2013 Oct 15;112(8):1142-7. doi: 10.1016/j.amjcard.2013.05.063. Epub 2013 Jul 4.

  PMID: 23831166 BACKGROUND

• Virani SS, Alonso A, Aparicio HJ, Benjamin EJ, Bittencourt MS, Callaway CW, Carson AP, Chamberlain AM, Cheng S, Delling FN, Elkind MSV, Evenson KR, Ferguson JF, Gupta DK, Khan SS, Kissela BM, Knutson KL, Lee CD, Lewis TT, Liu J, Loop MS, Lutsey PL, Ma J, Mackey J, Martin SS, Matchar DB, Mussolino ME, Navaneethan SD, Perak AM, Roth GA, Samad Z, Satou GM, Schroeder EB, Shah SH, Shay CM, Stokes A, VanWagner LB, Wang NY, Tsao CW; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2021 Update: A Report From the American Heart Association. Circulation. 2021 Feb 23;143(8):e254-e743. doi: 10.1161/CIR.0000000000000950. Epub 2021 Jan 27.

  PMID: 33501848 BACKGROUND

• Dieleman JL, Cao J, Chapin A, Chen C, Li Z, Liu A, Horst C, Kaldjian A, Matyasz T, Scott KW, Bui AL, Campbell M, Duber HC, Dunn AC, Flaxman AD, Fitzmaurice C, Naghavi M, Sadat N, Shieh P, Squires E, Yeung K, Murray CJL. US Health Care Spending by Payer and Health Condition, 1996-2016. JAMA. 2020 Mar 3;323(9):863-884. doi: 10.1001/jama.2020.0734.

  PMID: 32125402 BACKGROUND

• Marcus GM, Vittinghoff E, Whitman IR, Joyce S, Yang V, Nah G, Gerstenfeld EP, Moss JD, Lee RJ, Lee BK, Tseng ZH, Vedantham V, Olgin JE, Scheinman MM, Hsia H, Gladstone R, Fan S, Lee E, Fang C, Ogomori K, Fatch R, Hahn JA. Acute Consumption of Alcohol and Discrete Atrial Fibrillation Events. Ann Intern Med. 2021 Nov;174(11):1503-1509. doi: 10.7326/M21-0228. Epub 2021 Aug 31.

  PMID: 34461028 BACKGROUND

• Lin AL, Nah G, Tang JJ, Vittinghoff E, Dewland TA, Marcus GM. Cannabis, cocaine, methamphetamine, and opiates increase the risk of incident atrial fibrillation. Eur Heart J. 2022 Dec 14;43(47):4933-4942. doi: 10.1093/eurheartj/ehac558.

  PMID: 36257330 BACKGROUND

• Dewland TA, Vittinghoff E, Mandyam MC, Heckbert SR, Siscovick DS, Stein PK, Psaty BM, Sotoodehnia N, Gottdiener JS, Marcus GM. Atrial ectopy as a predictor of incident atrial fibrillation: a cohort study. Ann Intern Med. 2013 Dec 3;159(11):721-8. doi: 10.7326/0003-4819-159-11-201312030-00004.

  PMID: 24297188 BACKGROUND

• Marcus GM, Dewland TA. Premature Atrial Contractions: A Wolf in Sheep's Clothing? J Am Coll Cardiol. 2015 Jul 21;66(3):242-244. doi: 10.1016/j.jacc.2015.04.069. No abstract available.

  PMID: 26184617 BACKGROUND

• Dukes JW, Dewland TA, Vittinghoff E, Mandyam MC, Heckbert SR, Siscovick DS, Stein PK, Psaty BM, Sotoodehnia N, Gottdiener JS, Marcus GM. Ventricular Ectopy as a Predictor of Heart Failure and Death. J Am Coll Cardiol. 2015 Jul 14;66(2):101-9. doi: 10.1016/j.jacc.2015.04.062.

  PMID: 26160626 BACKGROUND

• Marcus GM. Evaluation and Management of Premature Ventricular Complexes. Circulation. 2020 Apr 28;141(17):1404-1418. doi: 10.1161/CIRCULATIONAHA.119.042434. Epub 2020 Apr 27.

  PMID: 32339046 BACKGROUND

• Marcus GM, Rosenthal DG, Nah G, Vittinghoff E, Fang C, Ogomori K, Joyce S, Yilmaz D, Yang V, Kessedjian T, Wilson E, Yang M, Chang K, Wall G, Olgin JE. Acute Effects of Coffee Consumption on Health among Ambulatory Adults. N Engl J Med. 2023 Mar 23;388(12):1092-1100. doi: 10.1056/NEJMoa2204737.

  PMID: 36947466 BACKGROUND

MeSH Terms

Conditions

Atrial Premature Complexes; Ventricular Premature Complexes; Marijuana Abuse; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Cardiac Complexes, Premature; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Gregory M Marcus, MD, MAS

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2023
• First Posted: September 1, 2023
• Study Start: January 18, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)